Background

Gastroesophageal reflux frequently occurs in infants from birth to 2 years and is characterised by reflux and regurgitation often occurring during or immediately after feeds. These reflux events can range in both frequency and severity, and as the reflux events increase, they become increasingly distressing for both the infant and the parent. The study aimed to characterise the properties of a new infant liquid alginate product, determining the optimum gastric pH and dose volume for maximum reflux suppressant activity.

Methods

An in vitro infant stomach model was designed and developed that allowed products to be assessed for their reflux suppression activity. The validation of the model was completed by three independent operators comparing a milk control with infant Gaviscon to evaluate the models’ robustness, reproducibility, and ease of use. The model was used to establish reflux suppression activity of a new liquid alginate infant formulation in comparison with a milk control. Suppression activity was assessed at varying doses and pH within a physiological range.

Results

The validation study demonstrated no significant difference in refluxate volumes for the milk control within each reflux event when comparing across the three individual operators. Similarly, no statistical differences were seen during the infant Gaviscon experiments, confirming the robustness and reproducibility of the model. Significant reflux suppression was seen across the pH range (except at pH 5.75); the pH most advantageous for reflux suppression was pH 5.25. The optimum dose volume for consistently suppressing reflux was shown to be 5 ml. An infant stomach model was designed for evaluating reflux suppression activity of a formulation of liquid alginate. The optimum gastric pH and dose volume for demonstrating significant reflux suppression and the thickening of formula milk by the infant liquid alginate formulation were established.

Conclusion

This study confirms the mode of action of the alginate formula, demonstrating a superior reduction in the retrograde movement of in vitro gastric contents and volume of regurgitation. The study also demonstrates that optimal performance occurs in conditions that are in line physiologically with the target patient. Both actions compliment and support the efficacy of the alginate formulation as a reflux therapy agent.

中文翻译：

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一种新的体外模型，用于确定用于婴儿反流抑制的新型液体海藻酸盐的最佳 pH 值和剂量

背景

胃食管反流经常发生在出生至 2 岁的婴儿中，其特征是经常在进食期间或进食后立即发生反流和反流。这些反流事件的频率和严重程度各不相同，随着反流事件的增加，它们对婴儿和父母双方都变得越来越痛苦。该研究旨在表征一种新的婴儿液体海藻酸盐产品的特性，确定最佳胃酸 pH 值和最大反流抑制活性的剂量。

方法

设计和开发了一种体外婴儿胃模型，可以评估产品的反流抑制活性。模型的验证由三个独立的操作员完成，将牛奶控制与婴儿 Gaviscon 进行比较，以评估模型的稳健性、再现性和易用性。该模型用于建立与乳汁对照相比的新型液体藻酸盐婴儿配方的反流抑制活性。在生理范围内的不同剂量和 pH 值下评估抑制活性。

结果

验证研究表明，在三个独立操作员之间进行比较时，每个回流事件中牛奶控制的回流体积没有显着差异。同样，在婴儿 Gaviscon 实验中也没有发现统计学差异，证实了模型的稳健性和可重复性。在整个 pH 范围内（pH 5.75 除外）都观察到了显着的回流抑制；最有利于抑制回流的 pH 值为 5.25。一致抑制反流的最佳剂量体积显示为 5 ml。婴儿胃模型被设计用于评估液体藻酸盐制剂的反流抑制活性。确定了用于证明婴儿液体藻酸盐制剂显着抑制反流和配方乳增稠的最佳胃 pH 值和剂量体积。

结论

该研究证实了藻酸盐配方的作用方式，证明了体外胃内容物逆行运动和反流量的显着减少。该研究还表明，最佳性能发生在与目标患者生理一致的条件下。这两种作用都补充并支持了藻酸盐制剂作为反流治疗剂的功效。